Manage Investigator sites and conduct on-site and centralized monitoring visits to ensure subject safety and data integrity.
Collaborate with cross-functional teams and external partners to maintain quality study oversight from start-up through close-out.
Support development of study documents, maintain TMF, and ensure inspection readiness while embodying core company values.
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The company combines cutting-edge technologies like optogenetics and spatial transcriptomics to identify novel drug targets, with a culture of integrity, collaboration, bravery, and dedication.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.
CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Complete the CRA Training Program (12-14 weeks) to gain the skills needed as a primary CRA.
Conduct site visits (PSSV, SIV, IMV, COV) and manage site performance, data quality, and patient safety.
Build strong relationships with site personnel and ensure effective communication with the Clinical Study Team.
BeOne is a global oncology company discovering and developing innovative, affordable treatments for cancer patients worldwide. Our growing global team of more than 11,000 colleagues fosters a collaborative, patients-first culture.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Independently manages the study start up activities for multi-center, US and/or global based studies.
Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the immune system, and are committed to continuous innovation in cell therapy.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Manage site activation and regulatory submissions for clinical trials in Spain.
Oversee contract and budget negotiations with sites to ensure timely approvals.
Collaborate with cross-functional teams to maintain project documentation and timelines.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine for rare diseases and oncology. The company is experiencing continued growth and values operational excellence and regulatory expertise.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Conduct on-site or remote monitoring visits to ensure site adequacy for clinical trials.
Train investigational site staff and support regulatory submissions as needed.
Mentor junior staff and perform co-monitoring visits to assess performance.
Ergomed Group provides clinical research, pharmacovigilance, and consulting services to biopharmaceutical companies, focusing on oncology and rare diseases. With a global team, they emphasize collaboration, kindness, and professional growth in a values-driven culture.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Manage clinical study vendors and ensure deliverables are on time, within budget, and compliant with FDA and ICH/GCP guidelines.
Support CRO collaboration, site start-up, study documentation, and risk mitigation with cross-functional teams.
Leverage AI tools and process improvements to enhance clinical operations productivity and quality.
This biotechnology company focuses on developing innovative oncology therapies. It offers a collaborative, multidisciplinary environment with opportunities to use AI-enabled tools and modern approaches to clinical operations.
Create eSource for new studies according to protocol specifications.
Distribute eSource to applicable sites and collaborate with local staff to ensure site-specific eSource requirements are implemented.
Serve as a subject matter expert for eSource creation and mentor clinical sites.
Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery within communities using cutting-edge technology and exceptional support services. Founded in 2018, the rapidly growing company currently operates 20+ sites across the US and Canada with a mission-driven culture focused on advancing medicine.
Lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization.
Develop, simplify, and maintain Clinical Operations SOPs, work instructions, and process documentation.
Act as senior Clinical Operations SME for audits, inspections, CAPAs, and strategic initiatives.
Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and data sciences. The company has a collaborative culture and supports remote work across Europe.
Manage regulatory submissions and site activation for clinical trials in Spain, ensuring compliance and timelines.
Negotiate site contracts and budgets, and coordinate with Competent Authorities and Ethics Committees.
Maintain project trackers, oversee essential documents, and support translation activities for patient materials.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel trial designs, biomarkers, and data analytics. They focus strongly on rare diseases and oncology, and their culture emphasizes innovation, collaboration, and regulatory excellence.
Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
Ensure high-quality deliverables within timelines and budget, from start-up through close-out.
Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.
Collect, review, and prepare site and regulatory documentation for UK clinical trial submissions.
Support regulatory submission preparation and ICF adaptations in compliance with ICH-GCP and local regulations.
Liaise with investigative sites to obtain, track, and resolve outstanding documentation and maintain study tracking systems.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We seek out diverse talent with a relentless commitment to innovation and impact.
Lead and oversee global clinical trials from inception to closure, managing cross-functional teams and vendors.
Ensure compliance with ICH/GCP and regulatory standards while driving recruitment and risk management strategies.
Manage study materials, systems (EDC, IRT, CTMS), and provide training to stakeholders.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines in immunology, oncology, neuroscience, and aesthetics. With a global presence, they emphasize integrity, innovation, and community service.